A Study of Evacetrapib in Participants With Abnormal Cholesterol

Dyslipidemia Clinical Trial

Official title:

A Phase 1b Study to Characterize the Pharmacokinetics of Evacetrapib and Potential for Accumulation After Dosing for 12, 24, and 52 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02168803
• Other study ID #: 15340
• Secondary ID: I1V-MC-EIBM
• Status: Completed
• Phase: Phase 1
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given once a day for 12, 24, and 52 weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream. Information about any side effects that may occur will also be collected.

This study will also evaluate how the study drug reacts in the body when given once a day for 12, 24 and 52 weeks and how the body responds and returns to normal when the treatment is complete. The relationship between study drug and the results from the how the study drug reacts in the body may be explored, if needed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria:

• Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR

• Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR

• Hypercholesterolemia on stable statin therapy for at least 3 month

• Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria:

• Have known allergies or intolerance to evacetrapib, related compounds

• Have history of recurrent rashes or chronic skin conditions

• Have significant history of or current chronic, active inflammatory conditions

• Have history or current evidence of significant neurological disorder

• Have long-standing diabetes that is insulin requiring

• Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Evacetrapib
Administered orally

Locations

Country	Name	City	State
United States	Covance	Dallas	Texas
United States	Covance Clinical Research Inc	Daytona Beach	Florida
United States	Covance Clinical Research Inc	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast])		Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
Primary	PK Parameters of Evacetrapib: Maximum Concentration (Cmax)		Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
Primary	PK Parameters of Evacetrapib: Terminal Half-life		Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
Secondary	PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level		Day -1, Day 8
Secondary	PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level		Day -1, Day 8
Secondary	PD Parameters of Evacetrapib: Total Cholesterol Level		Day -1, Day 8
Secondary	PD Parameters of Evacetrapib: Triglyceride Level		Day -1, Day 8